Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
21 Years
N/A
Both
Head and Neck Cancer
Trial Information
Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study
OBJECTIVES:
- Determine the frequency of complications associated with radiofrequency ablation (RFA)
in patients with low-risk papillary thyroid cancer undergoing thyroidectomy.
- Determine the utility of RFA as a treatment option for these patients.
OUTLINE: This is a pilot study.
An electrosurgical probe is placed by ultrasound guidance into the center of the thyroid
tumor. Patients undergo radiofrequency ablation directly to the tumor until the target
temperature is reached* for 5 minutes. Patients then undergo standard thyroidectomy.
NOTE: *Takes approximately 15-30 minutes to reach target temperature.
After completion of study treatment, patients are followed at day 1, between days 14-21, and
then periodically as deemed necessary.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Cytologically confirmed papillary thyroid cancer by fine needle aspiration
- Low-risk disease
- No poorly differentiated cytology
- Intrathyroidal tumor
- Located within the anterior two-thirds of the thyroid lobe
- Tumor not adjacent to the trachea by neck ultrasound
- Tumor ≤ 1.5 cm by neck ultrasound
- Requires thyroidectomy
- No cervical lymphadenopathy
- No multicentric tumors by neck ultrasound
- No evidence of lymph node metastasis
PATIENT CHARACTERISTICS:
Age
- Over 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Frequency of radiofrequency ablation-associated complications at 2 weeks
Safety Issue:
No
Principal Investigator
Electron Kebebew, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000410790
NCT ID:
NCT00103155
Start Date:
September 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage I papillary thyroid cancer
- Thyroid Neoplasms
- Head and Neck Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
